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Recruiting NCT07434518

A Real-World Study Evaluating the Efficacy and Safety of Adebrelimab in Patients With Advanced SCLC

— Observational Small Cell Lung Cancer (SCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adebrelimab (PD-L1 inhibitor).
Who it may be relevant to
Registry conditions: Small Cell Lung Cancer (SCLC). Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Real-world Study on the Efficacy and Safety of Adebrelimab in the Treatment of Advanced-stage Small Cell Lung Cancer

Overview

The goal of this observational study is to evaluate the safety and efficacy of adebrelimab in the perioperative and advanced-stage treatment of small cell lung cancer （SCLC） under real-world conditions. The main questions it aims to answer are: 1. The safety of adebrelimab treatment in patients with advanced SCLC under real-world conditions, with a specific focus on the incidence of grade ≥3 immune-related adverse events. Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab. 2. Observe and evaluate the efficacy of adebrelimab in patients with small cell lung cancer under real-world conditions. This includes overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Additionally, the study seeks to further explore the impact of patient baseline characteristics, such as brain metastases or liver metastases, and biomarkers on prognosis.

Interventions

  • Biological Adebrelimab (PD-L1 inhibitor)
    Investigating the efficacy and long-term safety of adebrelimab in different subgroups of SCLC patients (e.g., elderly patients, patients with comorbidities) in a real-world setting.

Primary outcome measures

  • Immune-related adverse events [Time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.]
Secondary outcome measures (7)
  • Overall survival (OS) [Time frame: From enrollment to the end of treatment at 12 months.]
  • Progression-free survival (PFS) [Time frame: From enrollment to the end of treatment at 12 months.]]
  • Objective response rate (ORR) [Time frame: From enrollment to the end of treatment at 12 months.]
  • Disease control rate (DCR) [Time frame: From enrollment to the end of treatment at 12 months.]
  • The density of immune cells in peripheral blood before and after treatment [Time frame: From enrollment to the end of treatment at 90 days.]
  • Incidence of Adverse Events [Time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.]
  • Incidence of Serious Adverse Events [Time frame: Safety monitoring begins when patients start receiving adebrelimab treatment and continues until 90 days after the last dose of adebrelimab.]

Eligibility criteria

Inclusion criteria

  • Histologically or cytologically confirmed extensive-stage small cell lung cancer;
  • Age ≥ 18 years;
  • The investigator determines that the patient is eligible for or is already receiving adebrelimab treatment.

Exclusion criteria

  • Patients concurrently receiving other immune-modulating drugs or therapies;
  • Patients currently participating in other interventional studies;
  • Patients with concurrent other malignancies;
  • Patients with missing key study-related data.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Shanghai General Hospital — Shanghai

Identifiers

NCT: NCT07434518 · 20250704064933814

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗